The following data is part of a premarket notification filed by Alpha Therapeutic Corp. with the FDA for Alpha Y-recipient Set.
Device ID | K833294 |
510k Number | K833294 |
Device Name: | ALPHA Y-RECIPIENT SET |
Classification | Set, Blood Transfusion |
Applicant | ALPHA THERAPEUTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-23 |
Decision Date | 1983-12-27 |